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Completed

NCT Number: NCT03050593

Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)

The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to HFrEF and healthy volunteers.

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Key information

Conditions

Patients With Heart Failure and Preserved Ejection Fraction - HFpEF Healthy Controls Group - Age and Sex-matched Patients With Heart Failure With Reduced Ejection Fraction - HFrEF

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to:

  • better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls)
  • provide mechanistic insights into pathophysiology
  • describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical features of heart failure or prior radiographic evidence in the absence of symptoms And Either ejection fraction > 50% (for HFpEF arm) or ejection fraction < 40% (for HFrEF arm)

Exclusion criteria

  • Myocardial infarction within the preceding 6 months
  • Suspected or confirmed cardiomyopathy (e.g. hypertrophic, infiltrative)
  • Suspected or confirmed constrictive pericarditis
  • Significant native valve disease (≥ moderate severity)
  • Known Significant lung disease (documented or FEV1< 30% or FVC < 50%)
  • Non-cardiovascular co-morbidity likely to cause death within 6 months (e.g. malignancy)
  • Significant renal failure (estimated GFR < 30 ml/min/m2)
  • Patient inability to provide informed consent (e.g. dementia)

Treatment and study plan

MRI scan, Echo scan

Diagnostic Test

Other names: cardiac MRI, trans thoracic echocardiography

Primary outcomes

  1. The composite end-point of all-cause mortality or repeat hospitalisation with heart failure

    Time frame: Minimum 6 month follow-up

Secondary outcomes

  1. The number of new clinical diagnoses detected by cardiac MRI

    Time frame: Through study completion, an average of 1 year

  2. Exercise capacity as assessed by the six-minute walk test

    Time frame: Through study completion, an average of 1 year

  3. Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction

Acronym: DIAMONDHFpEF

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2017
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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